BIOSECURE Act Sails Through House Passage, Lines Up Senate Vote

 

The U.S. House of Representatives on Monday overwhelmingly passed the bipartisan bill, which targets WuXi AppTec, WuXi Biologics and other Chinese biotech companies as potential national security risks.

The U.S. House of Representatives on Monday voted in favor of the BIOSECURE Act, which would restrict American companies from working with specific Chinese biotech companies—potentially putting more pressure on an already-strained drug supply chain.

The legislation gained bipartisan support with the House voting 306–81 to pass it, including 111 Democrats. Still, nearly all of the members of Congress who voted against the bill were Democrats.

Arguing in favor of the BIOSECURE Act, Rep. James Comer (R-Ky.), chairman of the House Committee on Oversight and Accountability, said in his prepared remarks that the bill is designed to “protect U.S. taxpayer dollars from flowing to biotechnology companies that are owned, operated, or controlled by China or other foreign adversaries.”

“This bill is a necessary step toward protecting American’s sensitive healthcare data from the CCP before these companies become more embedded in the U.S. economy, university systems, and federal contracting base,” Comer said. Reps. John Moolenaar (R-Mich.) and Raja Krishnamoorthi (D-Ill.), chair and ranking member of the House Select Committee on China, respectively, also made the case for its passage.

With Monday’s vote, the BIOSECURE Act will now move on to the Senate where strong bipartisan support is also likely. The Senate Committee on Homeland Security and Governmental Affairs passed a similar bill in in March 2024 with only one dissenting vote, according to STAT News.

Introduced in January 2024 by Krishnamoorthi and Reps Mike Gallaghher (R-Wis.), the BIOSECURE Act prohibits U.S. biopharma companies from working with Chinese contractors in the interest of national security. Five companies are currently blacklisted: WuXi Apptec, WuXi Biologics, Beijing Genomics Institute, MGI and Complete Genomics.

In May 2024, Congress amended its original bill with a grandfather clause which would allow existing contracts with Chinese companies until Jan. 1, 2032. The version that the House passed on Monday includes this leeway.

Some analysts contend the BIOSECURE Act could have far-reaching and potentially crippling consequences for the industry.

In an opinion piece in BioSpace on Monday, Jaxon Tan, founder of Momentum AI Communications, and Ivy Yang, columnist for the Financial Times Chinese, argue that the bill’s restrictions would disrupt not only the supply of drugs in the U.S., but also the ability of companies to conduct clinical trials. The ultimate result, according to Tan and Yang, is even more pressure on the country’s supply chain.

The BIOSECURE Act also reveals the weakness of domestic manufacturing capabilities in the U.S., Fernando Muzzio, professor of engineering at Rutgers University, told BioSpace last month. The U.S. has relied excessively on foreign manufacturing giants—mostly in China and India—and has neglected developing its homegrown capacity, Muzzio said.

https://www.biospace.com/policy/biosecure-act-sails-through-house-passage-lines-up-senate-vote

Centessa Positive Interim Phase 1 in Narcolepsy Study

 

• 2.5 mg dose restored normative wakefulness with mean sleep latency of 32 minutes as measured by the Maintenance of Wakefulness Test (MWT)
• Favorable safety and tolerability profile with no observations of frequently reported on-target adverse events (AEs) associated with other OX2R agonists, visual disturbances or hepatotoxicity as of the data cutoff date 1
• PK profile supports once-daily dosing
• Company plans to rapidly initiate Phase 2 studies of ORX750 in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH)

https://www.globenewswire.com/news-release/2024/09/10/2943494/0/en/Centessa-Announces-Positive-Interim-Phase-1-Clinical-Data-with-its-Novel-Orexin-Receptor-2-OX2R-Agonist-ORX750-in-Acutely-Sleep-Deprived-Healthy-Volunteers.html

'Leading Government Defense Ministry Awards BIO-key $500K In Follow-On Orders'

 BIO-key® International, Inc. (NASDAQ: BKYI), an innovative provider of workforce and customer identity and access management (IAM) solutions featuring Identity-Bound Biometrics (IBB) for phoneless, tokenless, passwordless and phish-resistant authentication experiences, announced that one of the world’s most respected government defense ministries has awarded BIO-key over $500K in new orders for BIO-key’s biometric user authentication solution pursuant to a three-year purchasing agreement.

The defense ministry continues to expand its deployment of BIO-key’s biometric authentication solution into new programs and user scenarios, delivering convenient phoneless, tokenless and passwordless authentication access to digital services for over 33,000 users. BIO-key expects additional awards in future periods as the defense ministry expands the use of its solution to additional defense ministry personnel.

https://www.globenewswire.com/news-release/2024/09/10/2943648/0/en/Leading-Government-Defense-Ministry-Awards-BIO-key-500K-In-Follow-On-Orders-for-Biometric-User-Authentication.html

Carisma and Moderna Expand Collaboration

 Building on successful pre-clinical in vivo CAR-M data in oncology, the companies will develop in vivo CAR-M for autoimmune diseases

Moderna nominated two autoimmune disease targets under the collaboration

Carisma is eligible to receive milestones and royalty payments

https://www.prnewswire.com/news-releases/carisma-and-moderna-expand-collaboration-to-develop-two-in-vivo-car-m-therapies-for-autoimmune-diseases-302242590.html

Alimera Sues ANI to Enforce Merger Agreement

 Alimera Has Filed Lawsuit in the Delaware Court of Chancery to Compel ANI to Close Merger Transaction and Honor its Contractual Obligations

Alimera Shareholders Approved Merger Agreement on September 4, Clearing Last Requirement for Closing

https://www.businesswire.com/news/home/20240909143534/en

Julie Su brought Calif. corruption to the White House — and Harris will keep her there

 President Biden’s nonchalance about Chinese spying, hacking and election interference is a cause for national worry — and his indifference to the Chinese threat extends even to his own White House.

Acting Secretary of Labor Julie Su’s catastrophic 2021 face-plant while serving as California’s labor secretary made China stronger, while making the world a more dangerous place for Americans and American ideals.

Acting Labor Secretary Julie Su speaks before President Joe Biden during a visit to the U.A. Local 190 Training Center in Ann Arbor, Mich., Friday, Sept. 6, 2024.AP

Yet Kamala Harris and her backers, including United Auto Workers President Shawn Fain, say they’d like Su to stay in her post after Jan. 20, despite the Senate’s refusal to confirm her nomination for 548 days and counting.

That makes her America’s longest-serving unconfirmed Cabinet officer.

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Su’s confirmation troubles stem from her time as California Gov. Gavin Newsom’s secretary of labor.

In that job, she ignored warnings about vulnerabilities in the state’s unemployment benefits system, claiming that tougher ID-verification standards would disproportionately hurt black and brown Californians. 

But her squeamishness left the system vulnerable: When COVID hit, Su lost some $32 billion to fraudsters who hacked the benefits program. 

That staggering sum — about a third of all American unemployment-insurance-fraud losses during the pandemic — included a $20 billion federal loan intended to backstop California’s pandemic-stressed unemployment trust fund. 

Multiple sources now say most of the lost money, about $26 billion, was captured by international crime gangs operating on behalf of foreign adversaries — and that taxpayer cash stolen by China’s Advanced Persistent Threat 41 and others is already being deployed against Americans and American interests. 

“The staggering fraud committed against California’s EDD during the pandemic is alarming, but the real danger lies in what those stolen billions are now funding,” said Paul Eckloff, a retired US Secret Service special agent who now works to thwart fraud at LexisNexis Risk Solutions. 

“Nation-states and transnational criminal groups are using this money to fuel illicit narcotics, human trafficking and activities that actively undermine our financial institutions and national security,” Eckloff told me.

“Even more alarming, these groups haven’t stopped — they’re continuing to target state programs across the country, promoting terror, crime, and undermining the rule of law,” he said.

If Su remains in a Harris administration, there’s likely worse news ahead: Those who benefitted most from California’s unemployment-insurance-fraud scandal have learned “an important lesson” from Su’s rise, said an intelligence expert. 

“They’ve learned that American governments are an easy mark because you won’t get caught,” the source said.

“What we have unfortunately seen is that more and more of these transnational crime groups [are] targeting US governments,” the expert explained, capitalizing on “antiquated tools and technology in government.”

Why is the Harris-Biden administration sticking with Julie Su despite bipartisan refusal to confirm her as labor secretary?

In Washington, Su has made things worse, using her federal authority to help California officials scrub from state documents any reference to the scandal. 

“It was a classic, bureaucratic ‘cover-your-ass’ move,” said a California state employee close to Newsom. Like others we spoke with, the source requested anonymity for fear of retribution.

Su has stonewalled journalists’ demands for public documents and refused to respond meaningfully to two congressional investigations of California’s COVID scandal. 

“My requests for information have been met with silence or evasive non-answers,” said Rep. Michelle Steel (R-Calif.). “Julie Su refuses to release vital information to the public or Congress about this taxpayer abuse.”

Nevertheless, Su’s star is rising in Kamala Harris’ Democratic Party, appearing as a featured speaker at multiple Democratic National Convention events last month. 

There’s ample evidence of personal affection between Harris and Su, both products of the Bay Area’s political monoculture.

When the vice president introduced Su to a union crowd in Philadelphia last summer, Harris pointedly gave her a verbal promotion: She first introduced Su as “acting Secretary Julie Su” and then — abandoning constitutional protocol requiring the Senate to confirm Cabinet members — ostentatiously corrected herself: “I’ll call her Labor Secretary. I’m not going to say the word ‘acting.’” 

Following Harris’ flattering introduction, Su thanked “my sister from California,” then went on a tear, eagerly telling the crowd that “enforcement” of business regulations is “the key” to achieving the left’s social goals. 

“Believe me,” she said, “you can’t achieve empowerment and equity without enforcement.” 

Su bragged, “I like to say we’re in a golden age of enforcement,” “empowering workers” and “building equity into everything we do.” 

In other words, America’s real enemy is Americans who run businesses.

Su’s Philadelphia audience of union activists heard her words as she intended them: as a call to class war.

They cheered the coming of a Golden Age of Enforcement of Everything — everything but official misfeasance and crimes committed against the United States by foreign adversaries.

Will Swaim is president of the California Policy Center and co-host of National Review’s Radio Free California podcast.

https://nypost.com/2024/09/09/opinion/harris-will-keep-julie-sus-cali-corruption-in-her-cabinet/